assessment and management of occupational risks in the nordic (scandinavian) countries

American Journal of Industrial Medicine 15: 615-626 (1989)

Assessment and Management of Occupational Risks in the Nordic (Scandinavian) Countries

Bo Holmberg, PhD, and Per Lundberg, PhD

Occupational health standards in the Scandinavian countries are of national concern and may thus vary from country to country. There is an internordic collaboration in the scientific criteria work, but there are also national formal procedures for standard setting. There is a greater tendency to accept eye, nose, or throat irritations as indices of harm than the American Conference of Governmental Industrial Hygienists (ACGIH) does. For organic solvents, neurotoxicity has been focused on for many years, although the differences between values in the ACGIH list and in the Nordic countries have diminished. Occupational standard setting in the Nordic countries is much influenced by technological feasibility and socioeconomic criteria. Sweden has a formalized procedure for the underlying scientific and transscientific assessments.

Key words: occupational standards, permissible exposure levels, criteria, Denmark, Finland, Iceland, Norway, Sweden

INTRODUCTION

The three kingdoms of Denmark (5.1 million inhabitants), Norway (4.2 million), and Sweden (8.4 million) and the two republics Finland (4.8 million) and Iceland (240,000 inhabitants) are often called the Nordic (or Scandinavian) countries. Historically, geographically, and culturally they have much in common, and they have close ties. They cooperate on some political issues. For instance, the labor sector and social security systems are closely interconnected, although most legislation is national. In many respects, the nations act individually and independently; in other areas, joint ventures and collaboration are common.

Risk management and risk control within the work environment are individual national issues, as are occupational standard setting and work environment legislation in general. However, there is some collaboration.

Department of Toxicology, National Institute of Occupational Health, Solna, Sweden. Address reprint requests to Dr. B. Holmberg, Department of Toxicology, National Institute of Occupa- tional Health, S-171 84 Solna, Sweden. Dr. B. Holmberg is Professor, Chairman of the Swedish Criteria Group. Dr. P. Lundberg is Scientific Secretary of the Swedish Criteria Group and Chairman of the Nordic Expert Group. Accepted for publication December 13, 1988.

0 1989 Alan R. Liss, Inc.

616 Holmberg and Lundberg

INTERNORDIC COLLABORATION

The Nordic Council of Ministers is an international body for the five govern- ments, established as a channel for collaboration, coordination, and exchange of ideas concerning various issues.

The Nordic Council of Ministers has established standing committees for specific issues: funding projects in cultural activities and scientific research, exchange of experts and governmental experience, etc. One such committee is the Nordic Senior Executive Committee for Occupational Environmental Matters, which, in late 1977, started a project to develop scientific criteria documents for occupational standard setting. These documents are meant to be used by the national regulatory authorities in the Nordic countries as a common scientific basis for setting national permissible exposure levels (PELs). The project is managed by a group of scientists, the Nordic Expert Group for Documentation of Occupational Exposure Limits. Since 1987 the group has consisted of one scientist from Denmark, Finland, Iceland, Norway, and Sweden; the scientists are specialists within the fields of toxicology, occupational medicine, epidemiology, pharmacology, and veterinary medicine, re- spectively. The criteria documents are published in Arbete och Hulsa, the scientific journal of the Swedish National Institute of Occupational Health (formerly the Research Department of the National Board of Occupational Safety and Health). Between 1978 and June 1988, 78 documents were published. They were initially written in a Scandinavian language with an English summary, but as of 1987, they have been translated into English and published once a year.

The regulatory authorities in the five countries present priority lists of substances to the Nordic Expert Group, which chooses the substances to be investigated and reported. Criteria for the decisions are the amount/volume of the substance in use, the number of workers exposed, and the potential toxicity of the substance. The task of writing a document is given, by the Expert Group, to a scientist in one of the five countries. The Expert Group then discusses the draft with the author, and after revision the document is published.

The documents are reviews of published scientific data. Where the data so permit, dose-effect and dose-response relationships are given in the conclusions. As of 1988, a critical effect is also defined [for definitions, see Nordberg et al., 19881. A PEL is not proposed. The task of standard setting is then addressed by the national authorities in each country.

NATIONAL ACTIVITIES Denmark

The Danish list of PELs [AT, 19881, which has legal status, is established by the National Labour Inspectorate. The list, revised every second year, contains a special section with intended changes and intended future exposure levels. The scientific basis is discussed in a special working group including representatives from the employers’ and employees’ organizations, and the technicaVeconomic implica- tions are evaluated in another working group with representatives from these organizations. Both groups are led by the Danish Work Environment Council. Discussions are based upon documentation from the Nordic Expert Group and the American Conference of Governmental Industrial Hygienists (ACGIH), as well as on published documentation from other sources.

Occupational Risks in Nordic Countries 617

If the intended changes are challenged, a summary of the published scientific literature is prepared by the Danish Institute of Occupational Health.

Finland

In 1981, the Finnish National Board of Labour Protection published a list of permissible occupational exposure levels [Tyosuojeluhallitus, 198 1 1. It covered substances, in the work environment, that had known adverse effects. The list did not have legal status but was to be used as a recommendation. It should be noted, though, that for six substances (asbestos, benzene, lead, carbon disulfide, hydrogen sulfide, and sulfur dioxide) the Finnish Government has set legal PELs. In preparation of the 1981 list, scientists from the Finnish Institute of Occupational Health provided the National Board with scientific documentation. This documentation has not been published, however.

As of 1987, the National Board of Labour Protection planned to publish a new list annually [Tyosuojeluhallitus, 19871 and also to publish the scientific basis for each proposed PEL. This task is assigned to a joint working group of experts from the National Board of Labour Protection and the Institute of Occupational Health. In their work they have hitherto relied upon the criteria documents from the Nordic Expert Group and the consensus reports from the Swedish Criteria Group (see below).

Iceland

In 1978, the Icelandic Administration of Occupational Safety and Health published a list of recommended PELs [Oryggiseftirlit rikisins, 19781. The list was a translation of the Danish list for that year. Publication of a revised list is planned. There is no published documentation, but the Administration uses the criteria documents from the Nordic Expert Group as well as available documentation from Sweden and from the United States.

Norway

Until 1974, the Norwegian Institute of Occupational Health produced a list of PELs that was mainly a translation of the ACGIH threshold limit values (TLVs). In 1978, the National Board of Occupational Safety and Health published a list based on the Danish PELs. The values are recommendations and have no legal status. They are based on medical and toxicological as well as on technological and economic considerations. Before a new list is published, the basis is discussed in a working group that includes representatives from the central organizations of the labor sector. Thus, the PELs are explicitly considered to be administrative norms rather than health-based values only. The list also includes proposed changes. The latest issue [Direktoratet for arbeidstilsynet, 19841 contains about 70 substances and intended changes.

The scientific documentation for the Norwegian values is not published, but the preamble to the list states that the documentation from the Nordic Expert Group, the ACGIH, the US NIOSH, and the Swedish Criteria Group are used. A national working group has documented the basis for identification and classification of carcinogenic substances as part of the preparation of the list of occupational PELs.


Sweden

The first list of occupational standards was a list of recommended exposure limits and was issued by the Institute of Occupational Medicine in 1969 [AMI, 19691. (In 1972 the Institute of Occupational Medicine became the Department of Occupa- tional Medicine within the National Board of Occupational Safety and Health [NBOSH]. In 1981 the name changed to the Research Department, still within the NBOSH. In 1987, the independent National Institute of Occupational Health [NIOH] was established from that research department.) Since 1974 [ASS, 19741 the National Board of Occupational Safety and Health (NBOSH) has issued lists of PELs. The values have had legal status since 1981 [ASS, 19811. The NBOSH publishes a newhevised list of permissible occupational exposure levels about every third year. The two latest lists were published in 1984 and 1987 [ASS, 1984, 19871.

During the 1970s there was no formal procedure for the scientific component of the occupational standard-setting procedure in Sweden. Scientific assessment of the biomedical literature was carried out in meetings by ad hoc constellations of scientists in the Research Department of the NBOSH. This scientific assessment was not formally written down and published. However, the administrative decision on the values was commented upon by the labor sector representatives before being acted upon by the NBOSH.

Since 1978, the standard setting has been structured in a multistep procedure. The first step is the critical evaluation of toxicological and medical data found in the literature and considered to be relevant for setting PELs. This is done by the Criteria Group [Lundberg and Holmberg, 19851. The Criteria Group consists of research scientists in toxicology, chemistry, occupational hygiene, and medicine within the National Institute of Occupational Health (NIOH), external university professors in occupational medicine, and scientific experts from the employers’ and employees’ central organizations.

Within the Criteria Group a consensus report is written, in which dose- effect/dose-response relationships are discussed and a critical effect [Nordberg et al., 1988; Nordberg, 19881 is defined. However, the Criteria Group makes no recommendations in terms of a specific numerical value. An appendix with analytical methods is also included in each report. The consensus reports are published yearly in both Swedish and English in Arbete och Hiilsa, the scientific peer-review journal of the NIOH. As of June 1988, the Criteria Group had published consensus reports on about 140 chemicals or generic groups. The administrative list of PELs from NBOSH currently contains about 280 chemicals or generic groups.

The important point in the process is that consensus is reached between the researchers and the scientific experts from the employers’ and employees’ organizations. The evaluations made are thus easily disseminated, and controversial issues in the scientific material are clarified in the Criteria Group. In many cases the consensus reports are written with an already-published criteria document as a scientific platform. Such criteria documents include those published by the Nordic Expert Group. The Criteria Group has requested a few separate criteria documents, written by individual scientists. So far (1988), 22 such documents have been published. Other information sources used by the Criteria Group are the documentation of the TLVs from the ACGIH and of the PELs from the Federal Republic of Germany. However, that documentation is not simply accepted; the original literature is carefully evaluated.


The next step in the risk management process is taken by another working group, the Regulations Group. This group consists of officials from the NBOSH and representatives from the employers’ and employees’ organizations. The majority of the members are different from those in the Criteria Group.

The Regulation Group performs a cost-benefit analysis, considers technological feasibility criteria, and analyzes the consequences of a possible change in PELs. After consideration of these issues, and of the scientific criteria, and of risk and exposure levels that might be acceptable, the Regulations Group proposes a new PEL. The data underlying the proposal made by the Regulations Group are not published, although they are officially available.

This proposal of a numerical value is then referred to several interested bodies in the society for additional consideration. After a further discussion within the NBOSH, the values are finally set by the Layman Board of the NBOSH. The Layman Board is another participatory decision body. In Sweden, a PEL is regarded as an administrative norm and is legally binding. The Regulations Group also considers the priorities for standard setting regularly and delivers to NIOH a list of top priority chemicals for the Criteria Group to assess. This list is the starting point for most of the work performed by the Criteria Group.

Of the 140 chemicals or generic groups of chemicals dealt with by the Criteria Group in consensus reports during the period 1979 to June 1988, a new permissible exposure level or a change in the existing PELs (published up to now) was set for about 25 chemicals. The changes in PELs have occurred concurrently with or as a direct result of the discussions in the Criteria Group or have appeared later. For a great many substances or generic groups, no change in the PEL was deemed necessary by the Regulations Group.

CRITERIA USED FOR OCCUPATIONAL STANDARD SETTINGS

The criteria used for setting occupational standards in the Nordic countries can be assessed only partially. Only Sweden publishes the scientific criteria which directly influence its PELs. However, even in this country, there is published national documentation for fewer than half of the substances listed. For many of the Swedish PELs, at least for many of the old values, documents from other countries, e.g., the US (NIOSH and the ACGIH) and FRG, have played an influential role.

In Sweden, 37 chemicals or generic groups have, during the 1970-198Os, been considered irritative to eyes, nose, or throat (Table I). The differences in values observed between the individual Nordic countries are mainly due to differences in the time the decisions were made. For dioxane, ethylene glycol, formaldehyde, mesityl oxide, tetrachloroethylene, trichloroethylene, and triethylamine, the PELs differ but no individual Nordic country has systematically lower or higher PELs. It appears to be a general tendency for the Nordic countries to accept imtation as a critical effect to a greater degree than, e.g., ACGIH [1987]. For initants, there is a tendency for the Nordic countries to have lower PELs than those on the ACGIH TLV list.

Carcinogenic/mutagenic/cytotoxic properties have influenced the standards for 25 substances or generic groups. The values are similar for most substances. Exceptions are ethylene oxide, arsenic, methyl iodide, 2-nitropropane, BaP, propylene oxide, styrene, and vinyl chloride. ACGIH may have classified a substance as a carcinogen, yet for many substances listed in Table 11, the ACGIH value is consid-


TABLE I. Substances Reviewed by the Criteria Group andor the Nordic Expert Group, With Exposure Limit Values (in mg/m3) From Sweden 1987 (S), Norway 1984 (N), Finland 1987 (SF), Denmark 1988 (DK), Iceland 1978 (IS), and, for Comparison, ACGIH 1987/88*

ACGIH Substance S N SF DK IS Acetaldehyde Acrylic acid Ally1 alcohol Ammonia Amy1 acetate 1-Butanol I-Butyl acetate Chlorine Copper Cyclohexanone Cyclopentanone Decane Dioxane Ethylene glycol Formaldehyde Furfural Furfuryl alcohol Hydrogen fluoride Hydrogen sulfide Isobutanol Isopropanol Man-made mineral

fibers(f/ml) Mesityl oxide Metacrylic acid Mineral spirits 1 -Nitropropane Oil mist Phenol Propyleneglycol mono-

methylether Some amines

e.g., diethylamine Some organic peroxides

e.g., methyl ethyl ketone peroxide

Tetrachloroethylene Trichloroethylene Triethy lamine Vanadium oxide Wood dust

45 30 5 18

500 80 700 1.5 1

100

500 90 130 0.6 20 20 1.7 14 150 500

1

70 500

3 4

-

-

-

-

30

1.5 140 110 40 0.2 3

90 30 5 18

525 150 710 3 1

100 __ -

18 50 0.6 8 20 2 15

1 50 490

- 40 70

90 5 19

360

30

-

1 200 I60 100 0.5 1-5

90

5 18

525 150 710 1.5 1

200

-

- - 90 125 1.3 20 20 4 15 I50 500

- 100 - - 90 5 19

360

30

1.5 335 160 10

0.5 5

45 30 5 18

525 150 710 1.5 1

100 - - 36 130 1.2 20 20 1.6 15 150 490

2 40 70

54 3 19

360

30

-

1 200 160 40

4 -

90

5 18

625 150 710 I .5 1

200

-

- -

90 260 1.2 20 20 2 15 150 980

-

100 -

-

90 5 19

360

75

1 200 160 100 0.5 5

180 30 5 18

530 I50 710 3 1

100 - - 90 125 1.5 8

40 2.5 14

300 980

10 60 70

525 90 5 19

360

30

1.5 335 270 40

1-5 -

. _

*Critical effect: irritation in eyes, nose, andlor throat.

erably higher than that in one or the other Nordic country. ACGIH has a basis for categorization of carcinogens different from the IARC-based Nordic system.

Twelve chemicals or generic groups are considered respiratory toxicants (Table 111) and have, considering temporal factors, rather similar values in the Nordic countries. They also compare fairly well with the ACGIH values.

During the past one and a half decades, chemicals acting on the central nervous


TABLE 11. Substances Reviewed by the Criteria Group a n d o r the Nordic Expert Group, With Exposure Limit Values (in mg/m3) From Sweden 1987 (S), Norway 1984 (N), Finland 1987 (SF), Denmark 1988 (DK), Iceland 1978 (IS), and, for Comparison, ACGIH 1987/88*

Substance S N SF DK IS ACGIH

4.5 4

0.2 0.5-1

0.002 0.002

- -

16 15

20 2200

0.5 0.5 35 3.6 0.5 0.5

- - 4 8 4.5 4 1.9 1.9 9 0.1 0.13 0.03 0.01 6 5 0.5

35 90

-

-

- -

0.005 0.04 12 12

I10 210 ? C 2 Vinyl chloride z 2 . J J 15 3

Acrylonitrile p- Aminoazobenzene Asbestos (f/ml) Benzene Beryllium Butadiene Chlorophenols

Chloroprene Chromium 1,2-Dibromo-3- chloropropane I ,2-Dichloroethane Diethylenetriamine Epichlorohydrine Ethylene oxide Hydrazine Inorganic arsenic Methyl iodide Nickel 2-Nitropropane Nitrosomorpholine Polyaromatic

hydrocarbons e.g., benzo(a)pyrene

Propylene oxide Styrene

e.g., pentachlorophenol

4.5

0.5

0.002

-

15

73

0.5

0.5 36

- 40 4 1.9 2.8 0.13 0.01

28 1

18 -

0.01 240 85

4

0.3 16 0.001

22

-

0.5 3.6 0.5

0.01 4 4 1.9 1.8 0.13 0.05 5.6 0.5

36 -

-

12 105

45

2 15 0.002

2200

-

0.5

0.5 36

-

80 4 1.9

36 0.13 0.05

28 1

90 -

- 240 210

4.5

0.2-2

0.002

-

30

22

0.5

0.5 35

- 40

4 10 2 0.1 0.2

10 1

35 -

- 50

215 3 10

*Critical effect: carcinogenic andlor mutagenic/cytotoxic.

system (Table IV) or on the peripheral nervous system have been a focus of scientific research in the Nordic countries, and data thus obtained were also seriously considered when standards were set. For 13 substances, most of them organic solvents, the neurotoxic effects were considered critical. Neurotoxic effects have certainly been considered previously for other substances, such as styrene, but in these cases, other toxicological effects have been considered to be the critical effect. It is interesting to note that the values for organic solvents, up to September 1988, differ little from the ACCIH TLVs of 1987 except for methyl ethyl ketone and 1,1? 1-trichloroethane. It should be mentioned, however, that in March 1987 the Swedish Government asked the National Board of Occupational Safety and Health to investigate the medical, technological, and economic consequences of a reduction of the Swedish PELs for organic solvents to half the 1984 levels. A reduction of the Swedish PELs for organic solvents will probably be decided upon in early 1989.

In Scandinavia generally, teratogenic/embryotoxic effects have been considered the critical effects for only a few chemicals. This is due merely to lack of data, rather than bias. Seven chemicals or groups of chemicals have occupational standards set on these criteria. The Nordic countries seem to have different opinions on PELs for the


TABLE 111. Substances Reviewed by the Criteria Group and/or the Nordic Expert Group, With Exposure Limit Values (in mg/m3) From Sweden 1987 (S), Norway 1984 (N), Finland 1987 (SF), Denmark 1988 (DK). Iceland 1978 (IS). and, for CornDarison. ACGIH 1987/88*


Aluminum Carbon dust Cobalt Cotton dust Diisocyanates

e.g., TDI Hexamethylenetetramine Moly bdenum Morpholine Nitrogen dioxide Ozone Piperazine Sulfur dioxide

2 2 2 2 2 2 2 3 2

0.05 0.05 0.05 0.05 0.05 0.05 0.5 0.5 5 0.5 0.5 0.2

- - -

0.04 3 5

70 4 0.2 0.3 5

0.035 0.035

5 5 70 70 3.5 6 0.2 0.2

1 5 5

- -

-

0.035

5 70 5.6 0.2

5

-

-

0.07 0.04

5 5 70 70 9 6 0.2 0.2

- -

5 5

*Critical effect: effects on the respiratory system.

TABLE IV. Substances Reviewed by the Criteria Group and/or the Nordic Expert Group, With Exposure Limit Values (in mg/rn3) From Sweden 1987 (S), Norway 1984 (N), Finland 1987 (SF), Denmark 1988 (DK), Iceland 1978 (IS), and, for Comparison, ACGIH 1987/88*


Cyclohexane Ethyl benzene Halothane n-Hexane Inorganic lead Inorganic mercury Methanol Methyl bromide Methyl ethyl ketone Ropy leneglycol

Toluene 1 , 1 , I -Trichloroethane Xylenes

dinitrate

1000 200 40

180 0.1 0.05

250 60

150

0.7 200 400 200

1050 435 40

180 - 0.05

260 20

440

2 280 540 330

1050 435

8 180

0.1 0.05

260 60

440

0.2 375 540 435

1050 217 40

180 0.1 0.05

260 20

290

0.2 190 540 217

1050 435

360 -

0.1 0.05

260 60

440

2 375 540 435

1050 435

180 -

0.15 0.05

260 20

590

0.3 375

1900 435

*Critical effect: neurotoxic effects.

glycols (Table V). ACGIH recommends lower values for these particular substances but has the same assessment on the other chemicals as the Nordic countries do.

It should, however, be emphasized that occupational standard setting is an administrative concern in the Nordic countries and that technological feasibility and socioeconomic considerations as well as other administrative factors may lead a step further down on the scale of exposure levels. This transscientific set of criteria seems to be used when exposure can be controlled at a level lower than the maximum supported by toxicological and medical arguments [Holmberg, 1981; Holm et al., 19821. In Sweden such criteria have been used for, e.g., BaP, ethylene dichloride, methyl chloroform, trichloroethylene, tetrachloroethylene, and vinyl chloride.

Differences in values for these substances on the national lists of the individual


TABLE V. Substances Reviewed by the Criteria Group andlor the Nordic Expert Group, With Exposure Limit Values (in mg/m3) From Sweden 1987 (S), Norway 1984 (N), Finland 1987 (SF), Denmark 1988 (DK), Iceland 1978 (IS), and, for Comparison, ACGIH 1987/88*


Acrylonitrile 4.5 4 4.5 4 45 4.5 Benomyl 10 10 5 - 10 Boric acid - -

Ethylgycol 70 I85 I85 18.5 370 19 Methylglycol 30 80 80 16 80 16 Nitrous oxide 180 180 - 180 Phthalates

-

- - - -

- -

e.g., Di-(2-ethylhexyl)- phthalate 5 5 5 5 5 5

*Critical effect: teratogenic/embryotoxic effects.

Nordic countries may reflect differences in assessments of what is technologically and socioeconomically feasible in each country or may even reflect the opinion that toxicologicaUmedica1 data only should be considered. This latter approach is still popular in the world today. ACGIH seems, e.g., to accept only biomedical data (at least consciously) as standard setting-although the ACGIH attitude has been debated elsewhere [Castleman and Ziem, 19881.

THE SPECIAL ISSUE OF CLASSIFYING CARCINOGENIC SUBSTANCES

The first classification of occupational carcinogens in the Nordic countries appeared in Sweden in 1974, and it has since been extended. The other Nordic countries followed, and gradually increasing lists of carcinogens have appeared as appendices to the national lists of occupational standards [cf. AT, 198 1; Direktoratet for arbeidstilsynet, 1980; Tyosuojeluhallitus, 19871.

Denmark The Danish list of carcinogens consists of 180 substances and is established by

the National Board of Environment and by the National Labour Inspection Services [Astrup Jensen, 1984; Svane, 19861. The criteria for listing a substance as a carcinogen coincide with IARC’s criteria 1A and 2A [IARC, 19821, i.e., sufficient evidence of carcinogenicity for humans and sufficient evidence of carcinogenicity for animals. The listing has no potency classification, and there may or may not be an established permissible exposure level. For asbestos and cytostatics, specific regulations are in force; asbestos was banned in 1980. No general regulation on handling of occupational carcinogens has yet been formulated.

Finland The Finnish listing of carcinogens in the work environment covers 172 sub-

stances that are subdivided into three groups. Group 1 consists of substances permitted for use in scientific research and after permission from the Labour Inspec- torate. This group presently contains 15 substances. Group 2 (seven substances) substances have a limited use, and their handling is regulated in detail by the Labour Inspectorate. The final group, group 3 , consists of 150 substances or generic groups


the handling of which is regulated by a general code of practice. Finland is the only Nordic country having a registry of workers and workplaces handling carcinogens [Rantanen, 19881.

Iceland

The Icelandic list [Oryggiseftirlit rikisins, 19781 has no separate listing of carcinogens, although 18 of the substances for which permissible exposure levels are given are specially marked as carcinogens. The 1988 list will probably have a separate listing of carcinogens.

Norway

The Norwegian Environment Pollution Control Authority publishes a list of carcinogens presently containing 150 substances [Norseth, 1986a,b]. The Directory of Labour Inspection, responsible for the enforcement of the Work Environment Act, has a smaller list of 34 occupational carcinogens. However, the two governmental authorities are collaborating, and a classification defined by one authority is accepted by the other without further modification. The criteria for classification of carcinogens are identical with the Danish criteria and are based upon epidemiological data or experimental data. Experimental data will be accepted if there is at least one positive mammalian long-term bioassay supplemented by positive short-term test data from two different test systems.

Sweden

The scientific basis underlying the listing of a chemical as a carcinogen in the National Board of Occupational Safety and Health list of permissible exposure levels has been assessed by individual scientists at the NIOH. The Criteria Group has not been much involved with that classification per se.

The Swedish list of carcinogens presently consists of 70 substances or substance groups listed according to the following biomedical criteria: one conclusive epide- miologic study or at least one positive long-term animal study. The substances are not classified according to potency but are subdivided into three classes [Holm and Holmberg, 19871: A) prohibited chemicals; B) chemicals used only after permission and regulation by the Labour Inspectorate; and C) chemicals with no other regulation than a PEL. The placing of a substance into one of the three classes, A, B, or C, is based mainly upon technological and socioeconomic considerations. The critical effect upon which the PEL is based may be cancer or a related biological effect (as, e.g., for asbestos and benzene), but usually the PEL is based upon technological feasibility criteria (vinyl chloride) or biomedical criteria other than cancer. Sweden also has a code of practice for some carcinogens. These are asbestos, vinyl chloride and polyvinyl chloride, some nitrosoamines, ethylene oxide and propylene oxide, polychlorinated biphenyls, and cytostatics. Asbestos has been regulated more and more strictly since 1964. Crocidolite was banned in 1975 and most uses of asbestos were prohibited in 1981.

At the end of 1985, the Product Control Bureau at the Swedish Environmental Protection Agency published a list of 132 carcinogens divided into two groups: one major group called “very hazardous” and another group called “hazardous” containing 12 chemicals. The IARC criteria of sufficient and limited evidence for human


carcinogenicity and sufficient evidence for animal carcinogenicity apply for this listing.

On January 1, 1986, a new independent governmental agency, the Chemicals Inspectorate, was established. It has responsibility for listing, regulating, and super- vising work with toxic chemicals. The Chemicals Inspectorate took over the responsibility for that list and its implementation under the new Product Control Act, as a beginning to a more rigorous governmental control on import and use of chemicals. The National Board of Environmental Protection and the NBOSH, however, still supervise the parallel environmental and occupational regulations on carcinogens. The new Chemicals Inspectorate will continue to classify and list carcinogens. This agency also oversees the regulations of carcinogenic products [KEMI, 19871 and a certain harmonization with the other Nordic countries [Nordisk Ministerrad, 19851.

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